BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-FLEX

    MDR report key: 1728348 · Received June 7, 2010

    Report

    Report Number
    9611165-2010-00006
    Event Type
    Injury
    Date Received
    June 7, 2010
    Date of Event
    April 8, 2010
    Report Date
    June 2, 2010
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON REPORTS THERE IS NO LONG TERM IMPACT TO THE PATIENT. THE SPECIFIC INJECTOR INFORMATION WAS NOT RETAINED BY THE SURGEON. IT IS UNKNOWN WHICH INJECTOR WAS USED DURING THIS PROCEDURE. THE MANUFACTURING RECORDS FOR THE LENS WERE REVIEWED AND INDICATE ALL TESTS PASSED SUCCESSFULLY. FURTHER INVESTIGATION OF THE INJECTOR IS NOT POSSIBLE.

    Description of Event or Problem · 1

    THE DOCTOR STATES THE PROBLEM WAS DUE TO THE INJECTOR. WHEN THE SURGEON ADVANCED THE LENS, THERE WAS A SIGNIFICANT AMOUNT OF PRESSURE. WHEN THE OPTIC ENTERED INTO THE EYE, THE TRAILING HAPTIC WAS SEVERED IN HALF. THE SURGEON PROCEEDED TO REMOVE THE LENS AND IMPLANT ANOTHER LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FLEX INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 570C 039E8833043

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention